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Swiss views

April 22, 2014

Abolish breast cancer screening

The Swiss Medical Board, an independent group set up by their Ministry of Health to evaluate health technologies, has just reported on mammography screening for breast cancer – full report here, summary in the New Engl J Med (here), or for those without access Abolishing screening.Swiss.

The authors concluded that screening did more harm than good, and that women were being misled. They recommended that no new programmes be introduced, and that time limits be placed on existing ones.  Their reasoning was simple.

1. The evidence of benefit comes from rather old trials, and it’s not clear how relevant these are to modern practice. If mammography has improved, the benefit of screening today may be larger than the trials showed, but insofar as conventional treatments of breast cancer have improved, the benefit of screening will be smaller.

2. Any benefit comes at the expense of much harm.

3. The ratio of benefit to harm is hugely overestimated by most women. The authors demonstrated this discrepancy between perception and reality in a simple graphic.

breast screening graphic

Click on it. It’s worth a thousand words.

Jim Thornton

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Bathsheba

April 18, 2014

Regal misbehaviour

The story, of adultery and murder, is told in the second book of Samuel, Chapter 11. It is spring, the start of the fighting season, and King David’s army is busy destroying the Ammonites and besieging Rabbah. But the King is safely home in Jerusalem, caught up in palace intrigues.

One day, Bathsheba, bathing on the roof of an adjacent house tempts him.  He sends for her, one thing leads to another, and soon she is pregnant.  This is inconvenient, because she is married to one of David’s best soldiers, Uriah the Hittite, who will be surprised to find his wife pregnant when he eventually returns from the fight.  So David sends for Uriah, asks him how the war is going, and tells him to take a day off and go home to visit his wife, hoping thereby to let Bathsheba claim the child is Uriah’s – pregnancy dating was less accurate then. But Uriah doesn’t cooperate. He stays in the palace with David’s servants, and when David remonstrates:

“Camest thou not from thy journey? Why then didst thou not go down unto thine house?”

Uriah replies:

The ark, and Israel, and Judah, abide in tents; and my lord Joab, and the servants of my lord, are encamped in the open fields; shall I then go into mine house, to eat and to drink, and to lie with my wife? As thou livest, and as thy soul liveth, I will not do this thing.”

It’s a fine speech, contrasting the noble Uriah who will not even sleep with his own wife while his men are at war, with David who takes advantage of their absence.  David keeps Uriah back from the front for another day and even gets him drunk, but to no avail. He doesn’t go home.

David is ruthless. He writes to his general Joab instructing him to place Uriah at the front where the fighting is fiercest and then to withdraw so Uriah will be killed.  To make it worse he gets Uriah himself to carry the message, his own death warrant. The plan works and after a decent period of mourning Bathsheba marries David and bears his son.

But the Lord is displeased. He makes David understand the wickedness of what he has done, and causes the child to fall sick and die. The tough punishment is effective. David learns his lesson, and Bathsheba bears him another son, Solomon, from whose lineage Jesus is eventually born.

But who was really to blame?  Can’t kings take mistresses occasionally? Didn’t Bathsheba, a married woman, bathe on the roof where she knew David would see her?  The author of Matthew 1: 1-17 refuses even to name her in the list of Jesus’s ancestors.  She is simply “her that had been the wife of Uriah”.

Poor practice at BJOG

April 15, 2014

Hidden sample size change may have altered result

The IRIS trial in this months British Journal of Obstetrics & Gynaecology (BJOG) compared two speeds for administering MgS04 to mothers for fetal neuroprotection. The idea was that the slower one might reduce side effects. The trial report is here. It was registered here.  The planned sample size was 140, and the primary outcome any maternal adverse effect. The authors recruited 51 women and found no difference. But they hid their failure to achieve the intended sample by writing, at best incorrectly: “We aimed to recruit 51 women in total.”

Fortunately the editor asked Dwight Rouse, one of the most experienced obstetric triallists in the world, to write a commentary. He checked the trial registration site and picked up the sample size change: “the authors failed to acknowledge it, but should have, the intended sample size when they originally registered the trial was 140 women”.

Good for him. Not good for the editors to fail to make the authors correct the manuscript. Online readers will likely miss Rouse’s commentary.

But it gets worse.  The trial registration site now reads “Prospectively registered, target sample size 51, status complete”.  Only on the trial registration history here will you find that on 3 March 2013, the sample size was altered from 140 to 51 because “Sample size was based on a reduction in the experience of any adverse effects of the magnesium sulphate infusion (the primary outcome).”   This makes no sense. If the rate of the primary endpoint was lower than anticipated, it would be a reason for increasing the sample size!

Does it matter?  The results were as follows:

Any adverse event. 15/25 (60%) 60-minute loading; 21/26 (81%) 20-minute loading; risk ratio (RR) 0.74; 95% confidence interval (95% CI) 0.51-1.08. Adverse event leading to ceasing the loading treatment (1/25 in the 60-minute loading group; 2/26 in the 20-minute loading group; RR 0.52; 95% CI 0.05-5.38.  

The authors conclusion:

A slower rate of administering the loading dose of magnesium sulphate did not reduce the occurrence of maternal adverse effects overall. 

But if the trial had gone on to its planned sample size of 140 and if the percentage of adverse events in each group among the latter 89 had been the same as the first 51 – supposition, but a reasonable supposition – the results might have been 42/70 (60%) v 56/70 (81%). RR 0.74, 95% CI 0.59 – 0.92. P = 0.0078   i.e. slow infusion does reduce side effects.

I know I’m a boring obsessive, but if the question matters, and this one surely does because MgSO4 treatment reduces cerebral palsy, then getting the right answer matters.

This was government funded research.  If pharma did this sort of thing, imagine the fuss AllTrials.net would make.

Jim Thornton

Stockholm’s private maternity hospitals

April 6, 2014

BB Sophia opens

bbsophia

Sweden is far ahead of the UK when it comes to using independent maternity health providers.

Last week a new independent maternity hospital, BB Sophia, (click here) opened in Stockholm. Not a midwife led unit for normal deliveries, or a “too posh to push” place for the super rich to have Caesareans, but a full service maternity hospital, with midwives, obstetricians, anaesthetists and and its own neonatal unit.  It will deliver 4,000 babies a year, about the same as the average of the five government-run units in Stockholm.  And it’s the second large independent one in the city (click here for the other).  They both receive funding per birth from the government, so care remains free to patients.

Compare with the UK.  Last year a private midwife unit opened in Cheshire, and the only other one in the country, Tooting in London, closed due to lack of support. And that’s it. The whole of the UK, with a population six times larger than Sweden, doesn’t have a single independent maternity hospital serving NHS patients.

But Sweden is like us in one respect.  The usual band of establishment providers are complaining that the new unit will undermine the government ones.  The BMA would feel right at home.

Jim Thornton

First FGM Prosecution

March 29, 2014

What happened?

Female genital mutilation (FGM), the excision all or part of the foreskin/prepuce, clitoris or labia, which causes in some cases labial fusion and narrowing of the vaginal opening, is illegal in the UK.

FGC_Types

Campaigners want people who do it, and parents who allow it, to be prosecuted, and last week the director of public prosecutions, Alison Saunders, announced the first one. It’s an odd story. Here is the DPP statement.

“It was alleged that following a patient giving birth in November 2012, a doctor at the Whittington Hospital, in London, repaired FGM that had previously been performed on the patient, allegedly carrying out FGM himself.

“Having carefully considered all the available evidence, I have determined there is sufficient evidence and it would be in the public interest to prosecute Dr Dhanoun Dharmasena for an offence contrary to S1 (1) of the Female Genital Mutilation Act (2003).

“I have also determined that Hasan Mohamed should face one charge of intentionally encouraging an offence of FGM, contrary to section 44(1) of the Serious Crime Act (2007), and a second charge of aiding, abetting, counselling or procuring Dr Dharmasena to commit an offence contrary to S1 (1) of the Female Genital Mutilation Act (2003).”

The newspapers report that Dr Dharmasena had been an obstetrician at the Whittington in 2012 and that Mr Mohamed was related to the alleged victim.  What could possibly have happened?

The wording “repaired FGM that had previously been performed on the patient, allegedly carrying out FGM himself” suggests that a midline scar joining the labia across the anterior part of the vagina had torn during the delivery. This is a common post FGM injury. The torn edges bleed so obstetricians are obliged to repair them.  They can either place sutures to stop the bleeding but leave the labia separate, i.e return the anatomy more nearly to normal, or they can suture the labia back together across the vaginal opening, i.e. return to the post FGM pre-delivery anatomy.

Although the patient or her partner may request the latter for cultural or sexual reason, it is generally advised against.  The delivery has resolved one of the harmful effects of the FGM, and it could be argued that the doctor harms the woman a second time by rejoining the labia. But it’s a stretch to call such a repair FGM. Of course, if the doctor actually removed part or all of a healthy prepuce, clitoris, or labia, that would be FGM, but the DPP’s statement does not imply that.

I dealt with many such cases in the early 1980s when I worked in Africa.  My practice was to compromise. I sutured the anterior part of the labia across the vagina but left the posterior part open.  I argued that, by leaving a more open vagina, I was making intercourse easier for the woman, but that by repairing the anterior part, I was also respecting the couple’s culture.

It was a more innocent time. I’m glad there were no lawyers looking over my shoulder.

On the face of it this an extraordinary prosecution but perhaps there’s more to it. Ripe-tomato.org will watch the case with interest.

Jim Thornton

Short story

March 16, 2014

Lydia Davis

lydia davis

A long review of the short story writer in this week’s New Yorker (click here). An early story, The Thirteenth Woman, is two sentences and 138 words long. Not as short as Hemingway’s six word: “For sale: baby shoes, never worn”, but short.  Here it is.

The Thirteenth Woman

In a town of twelve women there was a thirteenth. No one admitted she lived there, no mail came for her, no one spoke of her, no one asked after her, no one sold bread to her, no one bought anything from her, no one returned her glance, no one knocked on her door, the rain did not fall on her, the sun never shone on her, the day never dawned for her, the night never fell for her; for her the weeks did not pass, the years did not roll by; her house was unencumbered, her garden unattended, her path not trod upon, her bed not slept in, her food not eaten, her clothes not worn; and in spite of all this she continued to live in the town without resenting what it did to her.

Lydia Davis

Mistakes happen

March 10, 2014

Glans amputation at neonatal circumcision

Last year ripe-tomato.org drew readers attention to the complications mentioned in a recent WHO manual for teaching neonatal circumcision (click here).  Some were serious and probably under-reported; clumsy doctors don’t publicise their mistakes. Parents may sue, but rarely publicise their son’s injury either, and he certainly won’t. We wondered if parents were fully informed.

A recent report (J Paed Urol, Dec 2013, click here, full text here glans amputation) should give cause for thought.  Some Canadian urologists describe six cases of accidental amputation, referred over a five or ten* year period. Two were successfully reattached, albeit with deformity; it’s too soon to know whether sensation was affected. The other three required multiple reconstructive operations. Warning – it’s illustrated.

It’s a nice paper. The authors show clearly how the problem happens when the foreskin has not been fully separated before surgery, and how it can be avoided by dividing adhesions between the glans and foreskin.  Doctors performing circumcision should read it carefully. Parents will want to ensure their son gets done by an expert –  or perhaps leave him intact.

Jim Thornton

* The abstract says the injuries occurred over a five year period, but the main text says over ten. Simple error. Mistakes happen!

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